Your surveillance plan must include a discussion of:
The plan objective(s) addressing the surveillance question(s) identified in our order;
The subject of the study, e.g., patients, the device, animals;
The variables and endpoints that will be used to answer the surveillance question, e.g., clinical parameters or outcomes;
The surveillance approach or methodology to be used;
Sample size and units of observation;
The investigator agreement, if applicable;
Sources of data, e.g., hospital records;
The data collection plan and forms;
The consent document, if applicable;
Institutional Review Board information, if applicable;
The patient followup plan, if applicable;
The procedures for monitoring conduct and progress of the surveillance;
An estimate of the duration of surveillance;
All data analyses and statistical tests planned;
The content and timing of reports.
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